Doxylamine succinate preparation method

A technology of doxylamine succinate and succinic acid is applied in the field of preparation of antihistamine drug doxylamine succinate, and the effect of simple operation is achieved

Inactive Publication Date: 2017-08-29
NANJING NONGKANG BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0012] In order to overcome the difficulties and deficiencies in the prior art, the inventors have found through a large number of experiments: adding an auxiliary base in the recrystall

Method used

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  • Doxylamine succinate preparation method

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Experimental program
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Effect test

Embodiment 1

[0023] Doxylamine succinate crude product 2.0g, acetone 8g, triethylamine 0.11g, heated under stirring to dissolve completely, then placed at 10°C-20°C for crystallization, filtered, and vacuum dried at 50°C to obtain white crystalline doxylamine succinate Sirilamine 1.46g, melting point 103.6-104.1°C, content 99.5%.

Embodiment 2

[0025] Doxylamine succinate crude product 2.0g, absolute ethanol 5g, diisopropylamine 0.3g, fully dissolved by heating under stirring, then placed at 10°C-20°C for crystallization, filtered, and vacuum dried at 50°C to obtain white crystalline amber Doxylamine acid 1.25g, melting point 103.2-104.3°C, content 99.3%.

Embodiment 3

[0027] 5.0g of crude doxylamine succinate, 20g of n-butanol, 0.8g of N,N-dimethyl-2-(diphenylmethoxy)ethylamine, heated under stirring to completely dissolve, and then placed at 10°C- Crystallize at 20°C, filter, and vacuum-dry at 50°C to obtain 3.75 g of white crystalline doxylamine succinate with a melting point of 105.2-106.0°C and a content of 99.8%.

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Abstract

The present invention provides a method for preparing high-purity doxylamine succinate by adding an auxiliary alkali in a doxylamine succinate crude product re-crystallization process. According to the present invention, the method has characteristics of simple operation, economy and environmental protection, and is suitable for industrial production.

Description

technical field [0001] The invention relates to a preparation method of an antihistamine drug doxylamine succinate. technical background [0002] Doxylamine is a fast-acting, short-lasting antihistamine drug, its chemical name is N, N-dimethyl-2-[1-phenyl-1-(2-pyridyl) ethyl Oxygen] ethylamine, structural formula is as follows: [0003] [0004] Clinically, its succinate can be used alone as a drug to improve sleep, and it is also commonly used in compound cold medicine as an ingredient to relieve symptoms such as nasal congestion, which has important clinical value. [0005] The synthesis of this compound has been reported in literature, such as Chinese patents CN102108059A, CN 103524403A, CN 103467365, etc. [0006] The United States Pharmacopoeia (such as USP35) stipulates that the melting point of doxylamine succinate should be 103~108°C, and the content should be 98.0~101.0%. The European Pharmacopoeia (such as EP7.0) stipulates that the melting point of doxylamine...

Claims

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Application Information

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IPC IPC(8): C07D213/30C07C55/10C07C51/41
CPCC07D213/30
Inventor 陈婷婷陈华明赵坚沈雨婧
Owner NANJING NONGKANG BIOTECH CO LTD
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